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Pharma Discipline
FDCA Form 37 Approved21 CFR Part 11 Compliant
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Dissolution Profiling Studies

Comparative, multimedia, and method development dissolution studies for solid oral dosage forms per USP and FDA guidance.

DissolutionCDPMultimediaBiowaiver
ApparatusUSP I, II, IV
Turnaround Time7–14 working days
Regulatory AcceptanceUSFDA, EMA, ICH
pH Media1.2, 4.5, 6.8, 7.4
● Lab Capacity ActiveForm 37 Certified

Study Protocol Support

Direct access to analytical specialists for study design, method validation, and turnaround timelines.

Submit Sample MatrixDownload Service Spec Sheet
Direct Technical Desk:+91 76240 54108
Service Scope & Regulatory Framework

Rigorous Scientific Execution Built for Global Regulatory Dossiers

Jarvogen offers comprehensive dissolution testing and profiling services for solid oral dosage forms including tablets, capsules, and modified-release products. Our dissolution studies support bioequivalence submissions, SUPAC changes, formulation development, and QC release testing. We use USP Apparatus I, II, and IV with automated sampling and HPLC/UV quantification.

Compendial Standards & Regulatory Alignment:
✓ USP <711>✓ ICH Q6A✓ FDA Dissolution Guidance✓ EMA Dissolution Guidance
Dual-Analyst Review

100% 4-eye verification of all chromatograms, integrations, and calculations before CoA generation.

ALCOA+ Data Integrity

Direct electronic data capture with immutable audit trails, restricted rights, and disaster backups.

Technical SpecificationscGLP Compliant

ApparatusUSP I, II, IV
Turnaround Time7–14 working days
Regulatory AcceptanceUSFDA, EMA, ICH
pH Media1.2, 4.5, 6.8, 7.4
Quality Credentials
FDCA Gujarat Form 37ICH Compliant (Q1–Q14)21 CFR Part 11
Key Analytical Capabilities

What's Covered in the Testing Scope

Comprehensive assay, stability, and characterization endpoints validated to global pharmacopoeial standards.

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Comparative dissolution profiling (CDP)Executed with validated SOPs and full raw data audit trails.
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Multimedia dissolution (pH 1.2, 4.5, 6.8)Executed with validated SOPs and full raw data audit trails.
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Dissolution method developmentExecuted with validated SOPs and full raw data audit trails.
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Dissolution method validationExecuted with validated SOPs and full raw data audit trails.
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f2 similarity factor calculationExecuted with validated SOPs and full raw data audit trails.
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Modified-release dissolution testingExecuted with validated SOPs and full raw data audit trails.
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Biowaiver support studiesExecuted with validated SOPs and full raw data audit trails.
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SUPAC dissolution studiesExecuted with validated SOPs and full raw data audit trails.
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Automated sampling with HPLC analysisExecuted with validated SOPs and full raw data audit trails.
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USP Apparatus I, II, and IVExecuted with validated SOPs and full raw data audit trails.
Qualified Laboratory Infrastructure

Validated Instrumentation & Data Systems

All instruments operate with full IQ/OQ/PQ qualification, automated audit trails, and 21 CFR Part 11 software packages.

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Dissolution Apparatus USP I (Basket)

Capsules and floating dosage forms

IQ/OQ/PQ QualifiedALCOA+ Audit Trail
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Dissolution Apparatus USP II (Paddle)

Tablets and most solid dosage forms

IQ/OQ/PQ QualifiedALCOA+ Audit Trail
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Dissolution Apparatus USP IV (Flow-through)

Low-solubility drugs, implants

IQ/OQ/PQ QualifiedALCOA+ Audit Trail
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HPLC (UV/PDA)

Drug quantification in dissolution samples

IQ/OQ/PQ QualifiedALCOA+ Audit Trail
Study Execution Lifecycle

How We Execute Your Study

Standardized 4-stage laboratory workflow ensuring traceability from sample intake to CoA release.

01
Stage 01

Method Selection

Dissolution apparatus, medium, and conditions selected per FDA/USP guidance.

02
Stage 02

Method Optimization

Sink conditions verified; discriminatory method developed if needed.

03
Stage 03

Profiling Study

Dissolution profiles generated at multiple pH values; 12 units per condition.

04
Stage 04

f2 Analysis & Report

Similarity factor (f2) calculated; dissolution report with regulatory conclusions.

Scientific Questions & Answers

Technical FAQs

Standard testing is delivered in 7–14 working days. Expedited priority slots are available upon request with dedicated instrument reservations and expedited QC review.
Ready for Sample Testing?

Initiate Your Dissolution Profiling Studies Study

Submit your sample matrix or request a pre-study analytical protocol discussion with our senior scientists today.

Schedule Scientific Consultation
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